Validation, Quality, Manufacturing Support

The process validation has the aim to give a documented act that the process is able to reply, consistently, an expected result or expected product specifications, in other words the product quality

Validation Support

PTM Consulting supports its customers in the implementation of the Risk-Based Validation and Continuous Process Verification approach to reduce the time and effort required by validation activities, while increasing productivity and profitability.

Process validation, according to the new validation approach defined by the EMA and FDA guidelines, must provide a risk-based approach to:

  • Define adequate requirements to facilitate system design and control activities;
  • Identify and evaluate how the process can generate incorrect correspondence to specifications by identifying and quantifying the link between CPP and CQA;
  • Ensure the state of control of the system through Risk Assessment, Control and Review activities that keep the risks within the defined level of acceptability during the production process;
  • Define the activities for continuous monitoring of process performance;
  • Reduce process validation activities over a traditional approach.

PTM methodology is able to translate the principles in guideline ICH Q9 and GMP “Qualification and Validation” Annex 15  into measurable services and tasks to:

  • Increase knowledge about the product and the process in order to build a robust and consistent control strategy;
  • Make decisions and set validation activities on the basis of objective and consistent rationale, also through the use of technical analysis tools (eg statistical tools).

Quality Support

Over the years PTM developed a range of services to support  activities in the Quality area,  to optimize these activities and to integrate risk concepts into the quality aspects.

In particular, these activities concern:

  • Rationalization and optimization of the conditions of use and storage of reagents and solvents,
  • Evaluation of the methods of managing and preserving counter samples of raw materials,
  • Conducting audit activities in the API, Pharma, Laboratories, Microbiology, etc. (scope to be defined),
  • Support for the definition of EIs,
  • Optimization of an analytical laboratory in terms of associated risks and work load management,
  • Risk-based approach to the qualification of laboratory equipment,
  • Management of OOTs.

Manufacturing Support

PTM Consulting also provides technical and methodological support  to Manufacturing Area. Quality by Design and a risk-based approach to achieve three fundamental goals:

  1. Increasing understanding of the product and its production process, focusing on collaboration between research functions and production functions;
  2. Increasing product and process robustness, leading to a reduction in product variability, and consequently a reduction in associated costs due to lack or  to “too much” quality;
  3. Use “scientific” methods to increase the robustness of the business.

Manufacturing area  services are conceived to optimize  process flow through time and cost reduction, out-specification, scheduling and improvement of test and sampling activities, definition of process monitoring and control activities.